BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER CUTTER 3:1 RATIO

    MDR report key: 3820666 · Received April 1, 2014

    Report

    Report Number
    1526350-2014-00240
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 31, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE IS MORE THAN ONE YEAR OLD AND HAS A NO PREVIOUS REPAIR HISTORY AT ZIMMER SURGICAL, INITIAL REPAIR. EVALUATION OF THE DEVICE OBSERVED MULTIPLE NICKS TO CUTTER BLADES. THE CUTTER DID NOT PASS THE TEST MESH AND WAS RETURNED TO THE CUSTOMER AS NON-REPAIRABLE. THE CAUSE OF THE REPORTED ISSUE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER PROPER HANDLING AS EVIDENCED BY THE DAMAGE TO THE CUTTER BLADES. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER CUTTER 3:1 RATIO WAS NOT WORKING CORRECTLY. DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE CUSTOMER, NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196415 ZIMMER SKIN GRAFT MESHER CUTTER 3:1 RATIO ZIMMER SKIN GRAFT MESHER CUTTER 3:1 RATIO GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIMMER SKIN GRAFT MESHER CUTTER 4:1 RATIO: 1107003